Merck's Pimicotinib Shows Durable Gains in TGCT Phase 3 Study

Merck KGaA, a premier science and technology company, today revealed up to-date Phase 3 data from the global MANEUVER trial of pimicotinib, an investigational CSF-1R antagonist developed in collaboration with Abbisko Therapeutics for the treatment of tenosynovial giant cell tumor (TGCT).

 Pimicotinib achieved a 14.3 month median follow-up with a robust increase in the objective response rate (ORR) from 54% at Week 25 to 76.2% (95% CI: 63.8–86.0), as assessed by a blinded independent review per RECIST v1.1 criteria.

Patients reported durable improvements in pain, mobility, and physical function, which suggests improved health-related quality of life and overall quality of life for these patients.

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“TGCT affects every aspect of a patient’s life—from physical pain and stiffness to their ability to work, care for family, and engage socially,” said Sydney Stern, PhD, MS, of TGCT Support, a program of the Life Raft Group.

The findings, presented at the ESMO Congress 2025, build on earlier data from ASCO, where pimicotinib achieved the highest ORR ever reported in a Phase 3 systemic therapy trial for TGCT. “Tumor responses deepen over time while patients continue to experience functional improvements,” said Prof. Niu Xiaohui of Beijing Jishuitan Hospital.

Patients who crossed over from placebo therapy to pimicotinib also demonstrated an ORR of 64.5% after 8.5 months, and pimicotinib demonstrated a consistent safety profile with no new safety signals, no liver toxicity or skin/hair pigmentation side effects, and overall side effects that were most mild and manageable.

“These results highlight pimicotinib’s potential to transform TGCT care,” said Dr. Victoria Zazulina of Merck KGaA. “We are working closely with global regulators to bring this promising therapy to patients as soon as possible.”